Mental State, Reported as Depression, Anxiety or StressEarly Phase 1NCT01169480
The Impact of Giving a Massage
A Early Phase 1 study testing Give a massage in people with Mental State, Reported as Depression, Anxiety or Stress, run by Parker Research Institute at 1 site in United States.
Trial summary
The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress . It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental State, Reported as Depression, Anxiety or Stress
- What is being tested?
- Give a massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults who are currently massage therapists, massage student or recent massage school graduates,
- Aged 18 to 65 years,
- Fluent in English
Who cannot join
- Current bruising,
- Fracture,
- Inflammatory arthritides,
- Peripheral neuropathy,
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Parker College School of Massage
Dallas, Texas, 75229
About this study
Official title: The Impact of Giving a Massage on Perceived Depression, Anxiety and Stress of Massage Therapists: A Randomized Clinical Trial
The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress . It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage.
Read the detailed description
Background It is well established that massage is beneficial for musculoskeletal conditions such as low back pain1-3 and neck pain. In addition, massage has been shown to alleviate depressive symptoms and reduce state anxiety and perceived stress. Furthermore, the therapeutic benefits of touch itself are recognized for many conditions and in many stages of life.
Thus far all massage research has investigated the impact of massage on the massage client, or the receiver of the massage. No peer-reviewed study was found that reported any biopsychosocial effects on the giver of the massage, the massage therapist.
With touch therapies such as massage, it is impossible to touch without being touched oneself. Therefore, it is speculated that the giver of a touch therapy will also receive a therapeutic benefit. In fact, it has been reported anecdotally that massage therapists often feel "better" after they give a massage than before. Feelings of exhilaration, enhanced well-being, and improved energy are common.
The aim of this study is to investigate if giving a massage impacts the state of mind of massage therapists, including depression, anxiety, and stress.
Methods
Participants For this study, 22 participants who are massage therapists, students of massage or recent graduates will be recruited from the Parker School of Massage Therapy(PSMT). Participants will be included if they are healthy and aged between 18 and 65 years old, and excluded if they currently have any of the following conditions: contusion, fracture, inflammatory arthritides, peripheral neuropathy, or pregnancy. Of the eligible volunteers, ten participants will be randomly selected to the experimental group, while the other ten participants will act as controls. All interventions will occur in the PSMT.
Interventions Participants in the experimental group will be asked to give one 50-minute Swedish massage to another volunteer. Control participants will be asked to wait in a classroom (i.e. do nothing) for the same amount of time.
Objectives The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress. It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage.
Outcomes The primary assessment measure will be the Depression, Anxiety, Stress Scales (DASS). The DASS is a set of three self-report scales measuring the affective states of depression ("D"), anxiety ("A") and stress ("S"). Each of the 21 items is scored from "0" (Did not apply to me at all) to "3" (Applied to me very much or most of the time). A template is used to score the test and subscore is achieved for each of the three subcategories. Subscores can range from 0 to 28+, with normals being at the lower end of the range. The DASS was found to have adequate convergent and discriminant validity and good reliability, including test-retest reliability.
Secondary outcome measure will be the State-Trait Anxiety Inventory-II (STAI). The STAI is a self-report measure that assesses both state anxiety (i.e. feelings at present moment) and trait anxiety (i.e. general feelings). The 40 items are measured on a 4-point Likert scale (1=Almost Never to 4=Almost Always). Scores are obtained for each subscale (State and Trait Anxiety) with the higher scores indicating higher anxiety. The STAI has been shown to be valuable in both research and clinical settings, and has been found to have high internal consistency, and excellent test-retest reliability.
Sample Size Sample size estimation was performed based on the primary outcome measure, the DASS. A minimum change in the total DASS score of 10 points is predicted using results from a similar effectiveness studies. Using the DSS Research Sample Size Calculator Software http://www.dssresearch.com/toolkit/sscalc/size_a2.asp), and a 5% level of confidence a total of 22 participants (11 per group) would be required for a statistical power of 0.81. We do not anticipate any loss-to-follow up and thus have not made any further adjustment for attrition.
Randomization \& Blinding Participants meeting the eligibility criteria will be pooled and a random drawing will determine which individuals will be in the experimental group and give the massage and which will act as controls. An independent assistant will perform the randomization process. Another independent assistant who is blind to group allocation will administer the assessment measures. Participants will be blind to group allocation for the duration of the study. While it is very difficult to blind participants when hands-on therapies are investigated, in this study this will be accomplished because giving a massage is a routine part of the day for these participants.
- Being tested
- Give a massage
- Keywords
- Massage, Therapist, Massage, DASS, Depression, Anxiety, State, Anxiety, Trait, Stress, Touch, Therapeutic Relationship
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Give a massageBehavioural
Participants in this arm will give a 50-minute Swedish massage to a volunteer.
| Study group | Role | What they receive |
|---|---|---|
| Massage Giver | Experimental | Participants in the experimental group will be asked to give one 50-minute Swedish massage to another volunteer. Receives: Behavioral: Give a massage |
| Passive Controls | No intervention | Participants in this arm will wait in a classroom (as usual) and do nothing out of their ordinary routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived, self-reported stress, anxiety and depression
The primary assessment measure will be perceived, self-reported stress, anxiety and depression as measured by the Depression, Anxiety, Stress Scales (DASS). The DASS is a set of three scales measuring the states of depression, anxiety and stress. Each of the 21 items is scored from "0" (Did not apply to me at all) to "3" (Applied to me very much or most of the time). A subscore is achieved for each of the three subcategories. Subscores can range from 0 to 28+. The DASS was found to have adequate convergent and discriminant validity and good reliability, including test-retest reliability.
Measured: Immediately before the 50-minute masage
Secondary outcomes (1)
Perceived, self-reported state and trait anxiety
Secondary outcome measure will be perceived, self-reported state and trait anxiety as measured by the State-Trait Anxiety Inventory-II (STAI). The STAI is a self-report measure that assesses both state anxiety and trait anxiety. The 40 items are measured on a 4-point Likert scale (1=Almost Never to 4=Almost Always). Scores are obtained for each subscale with the higher scores indicating higher anxiety. The STAI has been shown to be valuable in both research and clinical settings, and has been found to have high internal consistency,19 and excellent test-retest reliability.
Measured: Immediately before the 50-minute massage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental State, Reported as Depression, Anxiety or StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anne M. Jensen, Parker Research Institute
- Investigators
- M Jensen, DC, MS, MSc, Study director, Parker Research InstituteLavada A Smith, PhD, Principal investigator, Parker College School of MassageDrew Riffe, DC, Study chair, Parker College School of Massage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169480
- Sponsor's protocol ID
- Massage Study - I
- Status last verified
- Jun 2017
- First submitted
- 26 Apr 2010
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Giving a Massage on Perceived Depression, Anxiety and Stress of Massage Therapists: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01169480
- Acronym / sponsor ID
- Massage Study - I
- Keywords
- Massage, Therapist, Massage, DASS, Depression, Anxiety, State, Anxiety, Trait, Stress, Touch
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Parker Research InstituteUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress . It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage.
Detailed description
Background It is well established that massage is beneficial for musculoskeletal conditions such as low back pain1-3 and neck pain. In addition, massage has been shown to alleviate depressive symptoms and reduce state anxiety and perceived stress. Furthermore, the therapeutic benefits of touch itself are recognized for many conditions and in many stages of life.
Thus far all massage research has investigated the impact of massage on the massage client, or the receiver of the massage. No peer-reviewed study was found that reported any biopsychosocial effects on the giver of the massage, the massage therapist.
With touch therapies such as massage, it is impossible to touch without being touched oneself. Therefore, it is speculated that the giver of a touch therapy will also receive a therapeutic benefit. In fact, it has been reported anecdotally that massage therapists often feel "better" after they give a massage than before. Feelings of exhilaration, enhanced well-being, and improved energy are common.
The aim of this study is to investigate if giving a massage impacts the state of mind of massage therapists, including depression, anxiety, and stress.
Methods
Participants For this study, 22 participants who are massage therapists, students of massage or recent graduates will be recruited from the Parker School of Massage Therapy(PSMT). Participants will be included if they are healthy and aged between 18 and 65 years old, and excluded if they currently have any of the following conditions: contusion, fracture, inflammatory arthritides, peripheral neuropathy, or pregnancy. Of the eligible volunteers, ten participants will be randomly selected to the experimental group, while the other ten participants will act as controls. All interventions will occur in the PSMT.
Interventions Participants in the experimental group will be asked to give one 50-minute Swedish massage to another volunteer. Control participants will be asked to wait in a classroom (i.e. do nothing) for the same amount of time.
Objectives The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress. It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage.
Outcomes The primary assessment measure will be the Depression, Anxiety, Stress Scales (DASS). The DASS is a set of three self-report scales measuring the affective states of depression ("D"), anxiety ("A") and stress ("S"). Each of the 21 items is scored from "0" (Did not apply to me at all) to "3" (Applied to me very much or most of the time). A template is used to score the test and subscore is achieved for each of the three subcategories. Subscores can range from 0 to 28+, with normals being at the lower end of the range. The DASS was found to have adequate convergent and discriminant validity and good reliability, including test-retest reliability.
Secondary outcome measure will be the State-Trait Anxiety Inventory-II (STAI). The STAI is a self-report measure that assesses both state anxiety (i.e. feelings at present moment) and trait anxiety (i.e. general feelings). The 40 items are measured on a 4-point Likert scale (1=Almost Never to 4=Almost Always). Scores are obtained for each subscale (State and Trait Anxiety) with the higher scores indicating higher anxiety. The STAI has been shown to be valuable in both research and clinical settings, and has been found to have high internal consistency, and excellent test-retest reliability.
Sample Size Sample size estimation was performed based on the primary outcome measure, the DASS. A minimum change in the total DASS score of 10 points is predicted using results from a similar effectiveness studies. Using the DSS Research Sample Size Calculator Software http://www.dssresearch.com/toolkit/sscalc/size_a2.asp), and a 5% level of confidence a total of 22 participants (11 per group) would be required for a statistical power of 0.81. We do not anticipate any loss-to-follow up and thus have not made any further adjustment for attrition.
Randomization \& Blinding Participants meeting the eligibility criteria will be pooled and a random drawing will determine which individuals will be in the experimental group and give the massage and which will act as controls. An independent assistant will perform the randomization process. Another independent assistant who is blind to group allocation will administer the assessment measures. Participants will be blind to group allocation for the duration of the study. While it is very difficult to blind participants when hands-on therapies are investigated, in this study this will be accomplished because giving a massage is a routine part of the day for these participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Giver | Experimental | Behavioral: Give a massageParticipants in the experimental group will be asked to give one 50-minute Swedish massage to another volunteer. |
| Passive Controls | No intervention | –Participants in this arm will wait in a classroom (as usual) and do nothing out of their ordinary routines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults who are currently massage therapists, massage student or recent massage school graduates,
- Aged 18 to 65 years,
- Fluent in English
Key exclusion criteria (5 listed)
- Current bruising,
- Fracture,
- Inflammatory arthritides,
- Peripheral neuropathy,
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Give a massageParticipants in this arm will give a 50-minute Swedish massage to a volunteer. | Behavioural | Massage Giver |
Primary outcome
Perceived, self-reported stress, anxiety and depression
Time frame: Immediately before the 50-minute masage
The primary assessment measure will be perceived, self-reported stress, anxiety and depression as measured by the Depression, Anxiety, Stress Scales (DASS). The DASS is a set of three scales measuring the states of depression, anxiety and stress. Each of the 21 items is scored from "0" (Did not apply to me at all) to "3" (Applied to me very much or most of the time). A subscore is achieved for each of the three subcategories. Subscores can range from 0 to 28+. The DASS was found to have adequate convergent and discriminant validity and good reliability, including test-retest reliability.
1 secondary outcome
Perceived, self-reported state and trait anxiety
Time frame: Immediately before the 50-minute massage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Jensen, DC, MS, MSc study director
Parker Research Institute
Lavada A Smith, PhD principal investigator
Parker College School of Massage
Drew Riffe, DC study chair
Parker College School of Massage
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Give a massage in people with Mental State, Reported as Depression, Anxiety or Stress, run by Parker Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived, self-reported stress, anxiety and depression (time frame: Immediately before the 50-minute masage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.